A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects wit

Protocol: 
AAAQ5851
Phase: 
III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects wit

The purpose of the study is to compare the efficacy (how well the drug works) and safety (how well the drug is tolerated) of the study drug, PEGPH20 compared with Placebo (normal saline, that is, a mixture of salt and water with an amount of salt similar to body fluids) in combination with two chemotherapy drugs nab-paclitaxel (NAB) and gemcitabine (GEM). The study will answer whether the experimental treatment (PEGPH20 with NAB and GEM) is as good as or better than Placebo with NAB and GEM.

Are you Eligible? (Inclusion Criteria)

Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic site:
a. Available tumor tissue (formalin-fixed paraffin-embedded [FFPE] block preferred) with enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival block that meet specific tissue sample requirements (see Study Laboratory Manual). Archived or fresh tissue from the primary lesion or a metastatic lesion is required. Note: Fine needle aspirates or brushing biopsies will not be acceptable.
b. Archived resection specimens from the primary tumor without radiologic evidence of metastasis at the time of resection are not suitable to establish histological confirmation and require a new core biopsy of a metastatic site.

Subjects must be determined to be HA-high based on tumor biopsy that meets the requirements
noted in the previous inclusion criterion (see Study Laboratory Manual).

At least 1 tumor metastasis measurable on computed tomography (CT) scan per RECIST version 1.1 criteria, excluding the primary pancreatic lesion.

If a subject has had adjuvant therapy (chemotherapy for non-metastatic pancreatic cancer in
combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of adjuvant therapy, provided all toxicities have returned to baseline or <= Grade 1.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States